Sensitivity and Specificity of the Modified Helicobacter Test INFAI

WithdrawnOBSERVATIONAL
0
Timeline

Start Date

November 30, 2020

Primary Completion Date

January 31, 2021

Study Completion Date

February 28, 2021

Conditions
DyspepsiaGERD
Interventions
DIAGNOSTIC_TEST

Helicobacter Pylori Diagnostic

"Helicobacter Test INFAI with standard test Meal (1g citric acid as test meal and 75 mg C\^13 urea)~\+ The C\^13 UBT with the new test (REFEX). All patients will take Nexium mups (40 mg) orally once daily 30 min before breakfast from day 1 to 28."

DEVICE

Vital signs measurments

No description;

DIAGNOSTIC_TEST

endoscopy

Upper endoscopy where 6 biopsy samples will be obtained . Two biopsies will be taken from antrum and corpus for histology. The biopsies will be stained with Haematoxylin \& Eosin and Giemsa stains, and gastritis wilt be scored using the Updated Sydney System 12,13 Two biopsies will be taken from antrum and corpus for rapid urease test (RUT) and two biopsies will be taken from antrum and corpus for culture. All biopsy samples will be analysed in the local laboratory of the centre.

DRUG

Nexium Pill

patients will take Nexium mups 40 mg orally once daily, 30 min before breakfast Nexium mups 40 mg will be discontinued after Day 28.

Trial Locations (1)

94000

CHI de créteil, Créteil

All Listed Sponsors
lead

International Pharmaceutical Consultancy

OTHER